Chronic Obstructive Pulmonary Disease (COPD)Phase 3PROSPERONCT05742802
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
A Phase 3 study testing Tozorakimab 1 and Tozorakimab 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 335 sites in 37 countries.
Trial summary
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD. Read more about this study
- Who is it for?
- Ages 40 to 130 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tozorakimab 1 and Tozorakimab 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,713 participants
- Where
- 335 sitesin 37 countries
- Study dates
- 6 Mar 2023to 27 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
- Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
- FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
- Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
- Capable of giving signed informed consent.
Who cannot join
- Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
- Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
- Known history of:
- Severe allergic reaction to any monoclonal and polyclonal antibody.
- Allergy or reaction to any component of the IP formulation.
Show all 9Show fewer
- Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
- Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
- Participants who are not able to comply with the study requirements, procedures, and restrictions.
Trial locations and contacts
335 sites in 37 countries.
335 sites in 37 countries
United States46 sites
Research Site
Amarillo, Texas, 79106
Research Site
Baltimore, Maryland, 21224
Research Site
Baton Rouge, Louisiana, 70836
Research Site
Boerne, Texas, 78006
Research Site
Bowling Green, Kentucky, 42101
Research Site
Boynton Beach, Florida, 33435
Research Site
Buffalo, New York, 14203
Research Site
Cape Coral, Florida, 33990
Research Site
Colchester, Vermont, 05446
Research Site
Cudahy, Wisconsin, 53110
Research Site
DuBois, Pennsylvania, 15801
Research Site
Durham, North Carolina, 27705
Research Site
Evergreen Park, Illinois, 60805
Research Site
Fargo, North Dakota, 58104
Research Site
Farmington Hills, Michigan, 48336
Research Site
Franklin, Tennessee, 37067
Research Site
Gastonia, North Carolina, 28054
Research Site
Grand Rapids, Michigan, 49546
Research Site
Greenwood, Indiana, 46143
Research Site
Kansas City, Kansas, 66160
Research Site
Kingwood, Texas, 77339
Research Site
Lincoln, California, 95648
Research Site
McKinney, Texas, 75069
Research Site
Newport Beach, California, 92663
Research Site
Normal, Illinois, 61761
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Northridge, California, 91324
Research Site
Ormond Beach, Florida, 32174
Research Site
Pensacola, Florida, 32503
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Plantation, Florida, 33324
Research Site
Rochester, Minnesota, 55905
Research Site
Rock Hill, South Carolina, 29732
Research Site
Sayre, Pennsylvania, 18840
Research Site
Sheffield, Alabama, 35660
Research Site
St Louis, Missouri, 63110
Research Site
Tampa, Florida, 33607
Research Site
Tempe, Arizona, 85283
Research Site
Toledo, Ohio, 43617
Research Site
Tomball, Texas, 77375
Research Site
Tulsa, Oklahoma, 74133
Research Site
White Marsh, Maryland, 21162
Research Site
Williamsburg, Virginia, 23188
Research Site
Winter Park, Florida, 32789
Research Site
Zachary, Louisiana, 70791
China37 sites
Research Site
Baotou, 14010
Research Site
Beijing, 100057
Research Site
Beijing, 100144
Research Site
Changchun, 130021
Research Site
Changsha, 410015
Research Site
Chengdu, 610000
Research Site
Chengdu, 610014
Research Site
Chongqing, 400013
Research Site
Chongqing, 400037
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510180
Research Site
Haikou, 570311
Research Site
Hangzhou, 310006
Research Site
Hohhot, 010010
Research Site
Kunming, 650032
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210006
Research Site
Ningbo, 315010
Research Site
Shanghai, 200002
Research Site
Shanghai, 201199
Research Site
Shenyang, 110000
Research Site
Shenyang, 110004
Research Site
Shenzhen, 518020
Research Site
Shenzhen, 518053
Research Site
Shijiazhuang, 50051
Research Site
Suzhou, 215002
Research Site
Taiyuan, 030001
Research Site
Wuhan, 430022
Research Site
Wuxi, 214023
Research Site
Xiamen, 361004
Research Site
Xuzhou, 221000
Research Site
Xuzhou, 221009
Research Site
Yangzhou, 225001
Research Site
Yinchuan, 750004
Research Site
Zhanjiang, 524004
Research Site
Zunyi, 563100
Japan26 sites
Research Site
Asahikawa-shi, 078-8510
Research Site
Fujieda-shi, 426-8677
Research Site
Fukuoka, 819-8555
Research Site
Hamamatsu, 430-8525
Research Site
Hiroshima, 734-8530
Research Site
Iizuka-shi, 820-8505
Research Site
Iwata-shi, 438-8550
Research Site
Kanazawa, 920-8650
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kobe, 651-0072
Research Site
Matsusaka-shi, 515-8544
Research Site
Mizunami-shi, 509-6134
Research Site
Nagoya, 460-0001
Research Site
Obihiro, 080-0017
Research Site
Okayama, 700-8558
Research Site
Osaka, 531-0073
Research Site
Osaka, 543-8555
Research Site
Osaka, 545-8586
Research Site
Shinjuku-ku, 162-8655
Research Site
Shizuoka, 420-8630
Research Site
tabashi City, 173-8610
Research Site
Toshima-ku, 170-0003
Research Site
Toyonaka-shi, 560-8552
Research Site
Yokohama, 221-0855
Research Site
Yokohama, 223-0059
Research Site
Yokohama, 232-0024
Italy13 sites
Research Site
Bari, 70124
Research Site
Carrara, 54033
Research Site
Milan, 20142
Research Site
Milan, 20154
Research Site
Naples, 80131
Research Site
Roma, 00168
Research Site
Salerno, 84131
Research Site
Sassari, 07100
Research Site
Statte, 74010
Research Site
Telese Terme, 82037
Research Site
Tradate, 21049
Research Site
Vercelli, 13100
Research Site
Verona, 37134
Argentina11 sites
Research Site
Buenos Aires, C1121 ABE
Research Site
CABA, C1425BEN
Research Site
Ciudad de Buenos Aires, C1414AIF
Research Site
Córdoba, X5003DCE
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600GWV
Research Site
Mendoza, M5500CCG
Research Site
Quilmes, B1878FNR
Research Site
San Fernando, B1646EBJ
Research Site
San Juan Bautista, 1888
Research Site
San Miguel de Tucumán, T4000IAR
Brazil11 sites
Research Site
Blumenau, 89030-101
Research Site
Botucatu, 18618-686
Research Site
Brasília, 71681-603
Research Site
Curitiba, 80440-220
Research Site
Porto Alegre, 90035074
Research Site
Porto Alegre, 9061-000
Research Site
Porto Alegre, 91010-006
Research Site
Rio de Janeiro, 22061-080
Research Site
São Bernardo do Campo, 09750-420
Research Site
São Paulo, 01409-001
Research Site
São Paulo, 05403-000
Poland11 sites
Research Site
Bialystok, 15-044
Research Site
Bydgoszcz, 85-796
Research Site
Katowice, 40-648
Research Site
Krakow, 30-033
Research Site
Lublin, 20-412
Research Site
Ostróda, 14-100
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Poznan, 60-693
Research Site
Rzeszów, 35-205
Research Site
Sosnowiec, 41-208
Research Site
Wroclaw, 53-301
Bulgaria10 sites
Research Site
Dupnitsa, 2600
Research Site
Kozloduy, 3320
Research Site
Lovech, 5500
Research Site
Petrich, 2850
Research Site
Pleven, 5800
Research Site
Rousse, 7002
Research Site
Sliven, 8800
Research Site
Sofia, 1000
Research Site
Sofia, 1606
Research Site
Vratsa, 3000
Australia9 sites
Research Site
Campbelltown, 2560
Research Site
Frankstown, 3199
Research Site
Macquarie University, 2109
Research Site
Melbourne, 3000
Research Site
Nedlands, 6009
Research Site
Southport, 4215
Research Site
Spearwood, 6163
Research Site
Wollongong, 2500
Research Site
Woodville South, 5011
Germany9 sites
Research Site
Ahrensburg, 22926
Research Site
Bamberg, 96049
Research Site
Berlin, 10717
Research Site
Berlin, 12157
Research Site
Cologne, 51069
Research Site
Darmstadt, 64283
Research Site
Halle, 06108
Research Site
Marburg, 35037
Research Site
Peine, 31224
Mexico9 sites
Research Site
Benito Juárez, 03650
Research Site
Chihuahua City, 31000
Research Site
Guadalajara, 44100
Research Site
Guadalajara, 44200
Research Site
México, 01710
Research Site
Monterrey, 64460
Research Site
Morelia, 58000
Research Site
Oaxaca City, 68020
Research Site
Veracruz, 91910
Canada8 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Edmonton, Alberta, T5A 4L8
Research Site
Guelph, Ontario, N1H 6J2
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Québec, Quebec, G1G 5X1
Research Site
Québec, Quebec, G1V 4G5
Research Site
Sherwood Park, Alberta, T8L 0N2
Research Site
Winchester, Ontario, K0C 2K0
France8 sites
Research Site
Bordeaux, 33076
Research Site
Brest, 29609
Research Site
La Tronche, 38700
Research Site
Lyon, 69317
Research Site
Marseille, 13326
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Toulouse, 31300
India8 sites
Research Site
Belagavi, 590010
Research Site
Coimbatore, 641028
Research Site
Dehradun, 248001
Research Site
Jaipur, 302039
Research Site
Nagpur, 440012
Research Site
Nashik, 422007
Research Site
New Delhi, 110029
Research Site
Thane, 401107
Spain8 sites
Research Site
Galdakao, 48960
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Mérida, 06800
Research Site
Pozuelo de Alarcón, 28223
Research Site
Santander, 39008
Research Site
Valencia, 46010
Research Site
Zaragoza, 50009
Taiwan8 sites
Research Site
Hsinchu, 300
Research Site
Kaohsiung City, 80756
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taipei, 10002
Research Site
Taipei, 110
Research Site
Taoyuan, 333
Research Site
Yunlin, 640
Hungary7 sites
Research Site
Budapest, 1036
Research Site
Debrecen, 4032
Research Site
Edelény, 3780
Research Site
Encs, 3860
Research Site
Mosonmagyaróvár, 9200
Research Site
Nyíregyháza-Sóstóhegy, 4481
Research Site
Százhalombatta, 2440
Thailand7 sites
Research Site
Bang Kra So, 11000
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang, 22000
Research Site
Muang,, 55000
Research Site
Mueang, 20000
Research Site
Nakhon Ratchasima, 30000
United Kingdom7 sites
Research Site
Bradford, BD9 6RJ
Research Site
Corby, NN17 2UR
Research Site
Corby, NN18 9EZ
Research Site
High Wycombe, HP11 2QW
Research Site
Northwood, HA6 2RN
Research Site
Preston, PR2 9QB
Research Site
Shipley, BD18 3SA
Chile6 sites
Research Site
Chile, 7770484
Research Site
Curicó, 3341643
Research Site
Santiago, 7500010
Research Site
Santiago, 7500698
Research Site
Santiago, 8150000
Research Site
Talca, 3465584
Denmark6 sites
Research Site
Aalborg, 9000
Research Site
Copenhagen, 2400
Research Site
Hvidovre, 2650
Research Site
Næstved, 4700
Research Site
Roskilde, 4000
Research Site
Vejle, 7100
Greece6 sites
Research Site
Alexandroupoli, 68100
Research Site
Athens, 11527
Research Site
Exohi Thessaloniki, 57010
Research Site
Ioannina, 45500
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 57010
Israel6 sites
Research Site
Ashkelon, 78278
Research Site
Beersheba, 8410101
Research Site
Jerusalem, 9103102
Research Site
Kfar Saba, 4428164
Research Site
Rehovot, 76100
Research Site
Tel Aviv, 6423906
South Korea6 sites
Research Site
Daegu, 42415
Research Site
Incheon, 21431
Research Site
Jeonju, 54907
Research Site
Seoul, 05030
Research Site
Seoul, 06591
Research Site
Seoul, 07061
Belgium5 sites
Research Site
Brussels, 1000
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Namur, 5101
Czechia5 sites
Research Site
Brno, 625 00
Research Site
Jindřichův Hradec, 377 01
Research Site
Liberec, 460 63
Research Site
Olomouc, 779 00
Research Site
Rokycany, 337 01
Netherlands5 sites
Research Site
Eindhoven, 5623EJ
Research Site
Groningen, 9713 GZ
Research Site
Harderwijk, 3844 DG
Research Site
Heerlen, 6419 PC
Research Site
Zutphen, 7207 AE
Portugal5 sites
Research Site
Guimarães, 4835-235
Research Site
Lisbon, 1649-035
Research Site
Lisbon, 1998-018
Research Site
Matosinhos Municipality, 4454-509
Research Site
Vila Franca de Xira, 2600-009
Colombia4 sites
Research Site
Barranquilla, 80007
Research Site
Ibague, 730006
Research Site
Rionegro, 054047
Research Site
Zipaquirá, 200251
Finland4 sites
Research Site
Hämeenlinna, 13530
Research Site
Helsinki, 00290
Research Site
Kuopio, 70210
Research Site
Turku, 20520
Peru4 sites
Research Site
Lima, 15036
Research Site
Lima, 15046
Research Site
Lima, 15088
Research Site
Lima, LIMA 21
Romania4 sites
Research Site
Brasov, 500283
Research Site
Bucharest, 050159
Research Site
Cluj-Napoca, 400371
Research Site
Timișoara, 300002
Sweden4 sites
Research Site
Gothenburg, 413 46
Research Site
Gothenburg, 41345
Research Site
Lund, 222 22
Research Site
Stockholm, 11239
Norway3 sites
Research Site
Lørenskog, 1478
Research Site
Oslo, 450
Research Site
Tønsberg, 3103
Philippines3 sites
Research Site
Baguio City, 2600
Research Site
Cebu City, 6000
Research Site
Iloilo City, 5000
Turkey (Türkiye)3 sites
Research Site
Ankara, 06620
Research Site
Istanbul, 34854
Research Site
Mersin, 33343
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Hanoi, 10000
Research Site
Ho Chi Minh City, 700000
About this study
Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
Read the detailed description
Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations
- Being tested
- Tozorakimab 1, Tozorakimab 2, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Tozorakimab, MEDI3506, exacerbations, ICS, LABA/LAMA
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tozorakimab 1Combination product
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Tozorakimab 2Combination product
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
PlaceboCombination product
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Tozorakimab Dose 1 | Experimental | Injection subcutaneously Tozorakimab via pre-filled syringe. Receives: Combination Product: Tozorakimab 1 |
| Tozorakimab Dose 2 | Experimental | Injection subcutaneously Tozorakimab via pre-filled syringe. Receives: Combination Product: Tozorakimab 2 |
| Placebo | Placebo comparator | Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised rate of severe COPD exacerbations in former smokers.
The primary efficacy endpoint is the rate of severe COPD exacerbations.
Measured: Up to 104 weeks.
Secondary outcomes (8)
The annualised rate of severe COPD exacerbations
To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.
Measured: Up to 104 weeks.
Time to First Severe COPD Exacerbations
Time to first severe COPD exacerbation over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.
Measured: Up to 104 weeks.
Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.
To evaluate the long-term effect of Tozorakimab as an add on to SoC compared to with SoC plus placebo on COPD related health care utilisation. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.
Measured: Up to 104 weeks.
Time to first moderate-to-severe COPD exacerbation.
To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.
Measured: Up to 104 weeks.
Annualised rate of moderate to severe COPD exacerbations.
To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.
Measured: Up to 104 weeks.
Time to all-cause death.
To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.
Measured: Up to 104 weeks.
Trough serum concentrations of Tozorakimab over the treatment period.
Pharmacokinetics: concentrations of Tozorakimab in trough serum.
Measured: Up to 104 weeks.
Incidence of anti-drug antibodies.
Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.
Measured: Up to 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start6 Mar 2023
- Primary completion26 Feb 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,713 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742802
- Sponsor's protocol ID
- D9180C00008
- Other IDs
- 2022-501063-41-00
- Acronym
- PROSPERO
- Status last verified
- Jun 2026
- First submitted
- 17 Jan 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Watz H, Sciurba FC, Bonini M, Yanez A, Bourdin A, Zheng J, De Soyza A, Janssens W, van den Berge M, Xu JF, Saraiva GL, Jenkins M, Jimenez E, Lofdahl M, Li J, Mikosz M, Kishishita N, Jackson S, Johnson S, Patel R, Fageras M, Psallidas I. Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. BMJ Open Respir Res. 2026 Jul 20;13(1):e004145. doi: 10.1136/bmjresp-2026-004145.
PubMed 42476723
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
- ClinicalTrials.gov ID
- NCT05742802
- Acronym / sponsor ID
- PROSPERO / D9180C00008
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Tozorakimab, MEDI3506, exacerbations, ICS, LABA/LAMA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,713 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
Detailed description
Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tozorakimab Dose 1 | Experimental | Combination Product: Tozorakimab 1Injection subcutaneously Tozorakimab via pre-filled syringe. |
| Tozorakimab Dose 2 | Experimental | Combination Product: Tozorakimab 2Injection subcutaneously Tozorakimab via pre-filled syringe. |
| Placebo | Placebo comparator | Combination Product: PlaceboInjection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe. |
Who may qualify
- Ages
- 40 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
- Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
- FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
- Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
- Capable of giving signed informed consent.
Key exclusion criteria (9 listed)
- Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
- Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
- Known history of:
- Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tozorakimab 1Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study. | Combination product | Tozorakimab Dose 1 |
| Tozorakimab 2Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study. | Combination product | Tozorakimab Dose 2 |
| PlaceboParticipants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo. | Combination product | Placebo |
Primary outcome
Annualised rate of severe COPD exacerbations in former smokers.
Time frame: Up to 104 weeks.
The primary efficacy endpoint is the rate of severe COPD exacerbations.
8 secondary outcomes
The annualised rate of severe COPD exacerbations
Time frame: Up to 104 weeks.
Time to First Severe COPD Exacerbations
Time frame: Up to 104 weeks.
Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.
Time frame: Up to 104 weeks.
Time to first moderate-to-severe COPD exacerbation.
Time frame: Up to 104 weeks.
Annualised rate of moderate to severe COPD exacerbations.
Time frame: Up to 104 weeks.
Time to all-cause death.
Time frame: Up to 104 weeks.
Trough serum concentrations of Tozorakimab over the treatment period.
Time frame: Up to 104 weeks.
Incidence of anti-drug antibodies.
Time frame: Up to 104 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42476723Watz H, Sciurba FC, Bonini M, Yanez A, Bourdin A, Zheng J, De Soyza A, Janssens W, van den Berge M, Xu JF, Saraiva GL, Jenkins M, Jimenez E, Lofdahl M, Li J, Mikosz M, Kishishita N, Jackson S, Johnson S, Patel R, Fageras M, Psallidas I. Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. BMJ Open Respir Res. 2026 Jul 20;13(1):e004145. doi: 10.1136/bmjresp-2026-004145.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
335 sites in 37 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tozorakimab 1 and Tozorakimab 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 335 sites in 37 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 335 sites in United States, China, Japan, Italy, Argentina and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualised rate of severe COPD exacerbations in former smokers. (time frame: Up to 104 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05742802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.